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Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cl...

FDA Recall #D-1664-2012 — Class II — July 27, 2012

Recall #D-1664-2012 Date: July 27, 2012 Classification: Class II Status: Terminated

Product Description

Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541

Reason for Recall

Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.

Recalling Firm

Capco Custom Packaging Inc — Santa Fe Springs, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

14380 Bottles

Distribution

Nationwide and Canada

Code Information

Lot #: 4052, Exp 01/15; 4063, Exp 02/15; 4150, Exp 03/15.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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